Vivasure Commences Pivotal PATCH Study of PerQseal Closure Device System

May 2, 2023—Vivasure Medical, an Ireland-based company developing fully absorbable technology for percutaneous vessel closure, announced it has commenced the company’s PATCH pivotal study, which is evaluating the safety and efficacy of the Vivasure PerQseal closure device system. In March, the company announced FDA approval of an investigational device exemption to advance the study.

According to Vivasure, PerQseal is a sutureless, fully absorbable synthetic implant for large-bore vessel punctures that is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.

The multicenter, single-arm PATCH study will enroll up to 171 patients across the United States and up to 90 patients in up to eight European investigational sites. The data will support a premarket approval submission to the FDA in the United States.

The PATCH study’s principal investigator is William Gray, MD, who is System Chief in the Division of Cardiovascular Disease at Main Line Health and Codirector at the Lankenau Heart Institute in Philadelphia, Pennsylvania.

Vijay Iyer, MD, enrolled the study’s first patients at Kaleida Health’s Buffalo General Medical Center-Gates Vascular Institute in Buffalo, New York. Dr. Iyer is Chief of Cardiology at the University of Buffalo and Director, Structural Heart Interventions at Buffalo General Hospital.

“Large-bore closure can be challenging, and PerQseal is a promising technology for interventional cardiologists as a growing number of treatment options for patients utilize fully percutaneous approaches,” commented Dr. Iyer in Vivasure’s press release “I’m honored to participate in this study and look forward to gathering additional clinical evidence supporting this innovation’s potential benefits.”

Dr. Gray added, “With the recent proliferation of large-bore arterial access, there’s a moment at the completion of each procedure when vessel management is critical, and clinicians must quickly and effectively close it to reduce unnecessary, potentially life-threatening bleeding. I look forward to evaluating the PerQseal technology and its simplified, controlled technique—with the ultimate goal of reducing vascular complications for these patients.”